E386 – Disodium ethylenediaminetetraacetate

Additive E386

Other names for the additive (synonyms)

disodium ethylenediamine- tetra-acetate, disodium salt of EDTA, E 386, E-386

General Information

Additive E386 (disodium salt of EDTA), together with additive E385, belongs to the group of chelating agents — compounds capable of binding metal ions and forming stable complexes with them. In the food industry, it is used as an antioxidant, preservative, and stabilizer, preventing undesirable oxidation processes and changes in product color.

Ethylenediaminetetraacetic acid (EDTA) was first synthesized in the 1930s in Germany as an alternative to citric acid for water softening and technical processes. Later, its salts began to be actively used in medicine, food, and cosmetics. Today, the disodium salt of EDTA is produced industrially: ethylenediamine reacts with chloroacetic acid, after which the resulting acid is neutralized with sodium. The chemical formula of the substance is C₁₀H₁₄N₂Na₂O₈·2H₂O.

In pure form, additive E386 is a white crystalline powder without odor, well soluble in water. It is highly stable, non-volatile (does not evaporate or turn into a gaseous state under normal conditions), and is characterized by a high melting point. These properties make it convenient for use in the food industry and medicine.

Effects on the Body

Benefit of Additive E386

The mechanism of action of additive E386 in the human body is related to its chelating properties. It actively binds iron, copper, manganese, and other metal ions involved in oxidation processes.

In medicine, EDTA is used as a detoxifying agent in cases of heavy metal poisoning (lead, mercury, cadmium). Due to its chelating properties, it forms soluble complexes that are easily excreted from the body. Although other salts of EDTA are more often used in pharmacology, the disodium form also has certain applications.

Risks of Additive E386

In terms of metabolism, the disodium salt of EDTA behaves similarly to the calcium disodium salt (E385): it is poorly absorbed in the gastrointestinal tract and is excreted mainly unchanged. However, there is a key difference. While additive E385 already contains calcium, additive E386 can actively remove calcium from body tissues. This characteristic is considered the main risk and explains its restricted use.

Additive E386 can form chelates specifically with calcium ions in the human body. This may lead to hypocalcemia — a decrease in blood calcium levels, which is dangerous for the functioning of the nervous system, muscles, and heart. Prolonged calcium deficiency causes bone problems (osteoporosis), increases the risk of seizures, and can lead to cardiac arrhythmias.

Animal studies indicate that at high doses EDTA may irritate the gastric and intestinal mucosa, aggravate inflammation, and even promote the development of colorectal cancer. Moreover, when consumed in large amounts, the disodium salt of EDTA disrupts the mineral balance in the body. This is why international expert organizations consider additive E386 less safe compared to additive E385.

Uses

The disodium salt of EDTA is used in the food industry to prevent product spoilage and the formation of undesirable color shades. For example, in canning it prevents vegetables and fruits from darkening and stabilizes the color of canned beans or peas. In sauces and ready-to-eat meals, it helps preserve a bright appearance and taste. However, additive E386 is used much less frequently in the food industry than the calcium disodium form of EDTA.

Beyond food applications, the disodium salt of EDTA has technical uses: in cosmetics as a stabilizer in creams and shampoos, in pharmaceuticals as an excipient for injectable drugs, and in industry as a component of cleaning agents and a water softener.

Legal Status

In the European Union, additive E386 is not included in the list of permitted food additives according to Regulation (EC) No 1333/2008 and Regulation (EC) No 231/2012. This means its use in food products within the EU is prohibited.

In the United States, additive E386 is considered safe when used within established limits. The Food and Drug Administration (FDA) permits its use in certain categories of products, including canned beans, prepared sauces, and ready-to-eat meals. Maximum usage levels are determined by specific regulations.

In the Codex Alimentarius (international food safety standards), the disodium salt of EDTA is also included: documents STAN 192-1995 and CXG 36-1989 allow its use in certain types of food products.

In other countries, the status may differ. For example, in Canada and Australia the safer EDTA form — additive E385 — is more commonly used, while additive E386 has limited application. In many Asian countries, the additive remains permitted, but with clearly defined maximum levels of use.

You can read more about the properties of EDTA salts, the effects of additive E386 on human health, and other aspects in the material about additive E385.